CurrentCignaPolicy IP0565

Filspari (sparsentan) for primary IgA nephropathy

Defines Cigna's prior authorization, coverage criteria, and clinical requirements for Filspari (sparsentan) when used to slow kidney function decline in adults with biopsy-confirmed primary immunoglobulin A nephropathy (IgAN). Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyFilspari (sparsentan) for primary IgA nephropathy

Policy CodePolicy IP0565

Change TypeAnnual review with material updates (criteria thresholds, continuation criteria, exclusions)

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and document biopsy confirmation, quantitative proteinuria or UPCR, prior maximally tolerated ACEi/ARB use, and prescriber nephrology consultation to qualify for a 1-year approval.

SourceLink

POLICY UPDATE CHANGES

Added 'Patient is currently receiving Filspari' continuation criteria.

Revised high risk of disease progression threshold from UPCR ≥ 1.5 g/g or proteinuria ≥ 1 g/day to UPCR ≥ 0.8 g/g or proteinuria ≥ 0.5 g/day.

Added documentation requirements to support criteria.

Added exclusion that Filspari should not be used concomitantly with other medications indicated for IgAN (e.g., Fabhalta, Vanrafia).

1 yearapproval duration

≥18minimum age

≥30

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UPCR ≥0.8 or protein ≥0.5 g/dayhigh risk threshold

ACEi/ARB ≥12 wksprior RAS therapy

Coverage Criteria for Filspari (sparsentan)

Initial Therapy — Approve for 1 year if ALL of the following (A.i–vii).

Approve for 1 year if the patient meets ALL of the following (A.i–vii):

Initial Therapy Criteria: Patient is ≥ 18 years of age; AND the diagnosis has been confirmed by biopsy (documentation required); AND patient is at high risk of disease progression, defined by BOTH: (a) proteinuria meeting ONE of: (1) proteinuria ≥ 0.5 g/day (documentation required) OR (2) urine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g (documentation required); AND (b) patient has received the maximum or maximally tolerated dose of ONE of the following for ≥ 12 weeks prior to starting Filspari: (1) an angiotensin-converting enzyme inhibitor OR (2) an angiotensin receptor blocker; AND patient has received ≥ 3 months of optimized supportive care (including blood pressure management, lifestyle modification, and cardiovascular risk modification); AND patient has an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2; AND the medication will not be used in combination with any renin-angiotensin-aldosterone system inhibitors (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; AND the medication is prescribed by or in consultation with a nephrologist.see nodes

Documentation required for biopsy, quantitative proteinuria/UPCR, prior maximally tolerated ACEi/ARB (≥12 weeks), and ≥3 months optimized supportive care; approval duration = 1 year.

Current Filspari Recipient — Continuation approval for 1 year if ALL of the following (B.i–vi).

Approve for 1 year if the patient meets ALL of the following (B.i–vi):

Continuation Therapy Criteria: Patient is ≥ 18 years of age; AND the diagnosis has been confirmed by biopsy (documentation required); AND according to the prescriber, patient has had a response to Filspari (examples include reduction in UPCR or reduction in proteinuria from baseline); AND patient has an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2; AND the medication is not being used in combination with any renin-angiotensin-aldosterone system inhibitors (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists, or aliskiren; AND the medication is prescribed by or in consultation with a nephrologist.see nodes

Documentation of biopsy, evidence of response to Filspari, and recent eGFR required; approval duration = 1 year.

Filspari (sparsentan) is not medically necessary for any indication other than primary immunoglobulin A nephropathy (IgAN). Requests for Filspari where the diagnosis is not primary IgAN will be denied. In addition, the policy disallows concurrent administration of Filspari with other medications specifically indicated for IgAN (for example, Fabhalta and Vanrafia); such combination use is considered not medically necessary and will be denied.

The use of Filspari in combination with other agents approved for IgAN is discouraged because there are no controlled clinical trial data demonstrating additive benefit from combination therapy. Therefore, concurrent treatment with other IgAN‑indicated medications is considered not medically necessary and is specifically listed among the policy’s conditions not covered.

Coding and Thresholds

No specific billing codes providedmixed

No codes listed

Proteinuria / UPCR thresholds defining high risk of progression

Proteinuria thresholdProteinuria ≥ 0.5 g/day

UPCR thresholdUrine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g

Documentation requiredQuantitative proteinuria documented (24-hour urine protein or UPCR)

eGFR threshold requirement for approval

Minimum eGFR for approvaleGFR ≥ 30 mL/min/1.73 m2

Documentation requiredProvide most recent eGFR value in chart notes or labs

Prescriber Requirements, Documentation, and Denial Risks

Prior Authorization

Prior Authorization and Prescriber Requirement

Prior Authorization Required: Prior authorization is required for benefit coverage of Filspari. Approvals are provided for the duration noted in the criteria (1 year for initial and continuation therapy). Prescriber requirement: Filspari must be prescribed by or in consultation with a physician who specializes in the condition being treated (nephrologist for IgAN). Documentation is required where noted in criteria and must include patient-specific identifying information.

Prior authorization required
Prescribed by or in consultation with a nephrologist
Documentation required (see criteria)

Documentation Required

Initial Therapy Criteria

Initial therapy approvals (1 year) are allowed when ALL of the following are met: patient is ≥ 18 years; biopsy-confirmed IgA nephropathy [documentation required]; patient is at high risk of progression defined by BOTH: (a) proteinuria ≥ 0.5 g/day OR UPCR ≥ 0.8 g/g [documentation required], and (b) received maximum or maximally tolerated dose of an ACE inhibitor or ARB for ≥ 12 weeks prior to starting Filspari; the patient has received ≥ 3 months of optimized supportive care (blood pressure management, lifestyle modification, cardiovascular risk modification); eGFR ≥ 30 mL/min/1.73 m2; medication will not be used in combination with RAAS inhibitors, endothelin receptor antagonists, or aliskiren; and medication is prescribed by or in consultation with a nephrologist.

Background on Filspari (sparsentan)

Filspari (sparsentan) is an oral agent that combines endothelin receptor and angiotensin II receptor antagonism and is indicated to slow kidney function decline in adults with biopsy‑confirmed primary IgA nephropathy who are at risk of progressive disease. Clinical data supporting its use demonstrated reductions in proteinuria and slower eGFR decline versus comparator therapy; because of safety concerns it is managed with a REMS program for hepatotoxicity and embryo‑fetal toxicity. Initiation and continuation of therapy under this policy require documentation of biopsy‑confirmed primary IgAN and adherence to the program’s clinical criteria.

Key Definitions and Contraindications

Definition of high risk of disease progression (proteinuria ≥ 0.5 g/day or UPCR ≥ 0.8 g/g)

Definition (proteinuria)Proteinuria ≥ 0.5 g/day

Definition (UPCR)Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 g/g

Clinical contextHigh risk designation used to identify patients who may require additional treatment after biopsy-confirmed IgAN

Contraindicated combinations summary (RAAS inhibitors, ERAs, aliskiren)

Contraindicated agentsRenin-angiotensin-aldosterone system (RAAS) inhibitors (ACE inhibitors or ARBs) must be discontinued prior to initiation

Endothelin receptor antagonistsConcomitant use with endothelin receptor antagonists (ERAs) is contraindicated

Policy Revision History

2026-05-01Annual revisionLatest

Annual revision completed; policy effective date set to 05/01/2026 (administrative update).

2025-09-01Selected revision

Added exclusion discouraging concomitant use of Filspari with other medications indicated for IgAN (concomitant IgAN agents).

2025-07-01Selected revision

Added documentation requirements to support coverage criteria (e.g., biopsy confirmation, quantitative proteinuria, prior ACEi/ARB use).

Policy Summary

PayerCigna

PolicyFilspari (sparsentan) for primary IgA nephropathy

Policy CodePolicy IP0565

Change TypeAnnual review with material updates (criteria thresholds, continuation criteria, exclusions)

Effective DateMay 1, 2026

Next Review Date

SourceLink

On This Page

Both initial therapy and current Filspari recipients must meet this eGFR threshold

Prior RAS therapy duration (ACEi or ARB ≥ 12 weeks prior to initiation)

Required prior RAS therapyMaximum or maximally tolerated dose of an ACE inhibitor or angiotensin receptor blocker (ARB)

Minimum durationAt least 12 weeks prior to starting Filspari

DocumentationChart documentation of ACEi or ARB dosing and duration required

Initial approval duration = 1 year
Age ≥ 18 years
Biopsy confirmation required
High-risk proteinuria thresholds: ≥ 0.5 g/day or UPCR ≥ 0.8 g/g
Prior ACEi/ARB at maximum or maximally tolerated dose ≥ 12 weeks
Optimized supportive care ≥ 3 months
eGFR ≥ 30 mL/min/1.73 m2
No concomitant RAAS inhibitors, ERAs, or aliskiren
Prescribed by or in consultation with a nephrologist

Documentation Required

Continuation (Current User) Criteria

Continuation (current user) approvals (1 year) are allowed when ALL of the following are met: patient is ≥ 18 years; biopsy-confirmed IgA nephropathy [documentation required]; prescriber documents a response to Filspari (examples: reduction in UPCR or proteinuria from baseline); eGFR ≥ 30 mL/min/1.73 m2; medication is not used in combination with RAAS inhibitors, endothelin receptor antagonists, or aliskiren; and medication is prescribed by or in consultation with a nephrologist.

Continuation approval duration = 1 year
Age ≥ 18 years
Biopsy confirmation required
Documented response to therapy (e.g., reduction in UPCR/proteinuria)
eGFR ≥ 30 mL/min/1.73 m2
No concomitant RAAS inhibitors, ERAs, or aliskiren
Prescribed by or in consultation with a nephrologist

Denial Risk

Contraindicated Combination Therapies

Contraindicated combinations and not covered concomitant therapies: Filspari is contraindicated for use with renin-angiotensin-aldosterone system (RAAS) inhibitors (e.g., ACE inhibitors or ARBs), endothelin receptor antagonists (ERAs), or aliskiren. All RAAS inhibitors, ERAs, and/or aliskiren must be discontinued prior to initiation. Concurrent use with other medications indicated for IgAN (e.g., Fabhalta, Vanrafia) is not recommended and is considered not medically necessary.

Discontinue ACEi/ARB/ERA/aliskiren before initiation
No combination with other IgAN-specific agents (e.g., Fabhalta, Vanrafia)

Note

Supportive Care and Prior RAS Therapy

Supportive care and prior renin-angiotensin system (RAS) therapy requirement: Prior to initiation of Filspari patients must have received optimized supportive care for ≥ 3 months (blood pressure control, lifestyle modification, cardiovascular risk reduction). Patients must have received the maximum or maximally tolerated dose of an ACE inhibitor or ARB for ≥ 12 weeks prior to starting Filspari (examples of ACEi/ARB provided in policy).

Optimized supportive care ≥ 3 months
ACEi or ARB at maximum or maximally tolerated dose ≥ 12 weeks prior to initiation

Denial Risk

Missing Prior Authorization or Documentation

Missing prior authorization or required documentation (denial risk): Requests without a prior authorization or lacking required documentation (e.g., biopsy confirmation, quantitative proteinuria or UPCR, evidence of prior maximal ACEi/ARB therapy, eGFR labs, prescriber specialty/consultation) may be denied. Documentation may include chart notes, labs, claims records, and must include patient-identifying information.

Required documentation: biopsy report, proteinuria or UPCR values, evidence of ACEi/ARB use and duration, eGFR laboratory values, prescriber specialty/consultation note
Lack of prior authorization or missing documentation may result in denial

AliskirenConcomitant use with aliskiren is contraindicated

Policy consequenceUse in combination with these agents will lead to denial or is considered not medically necessary

2024-06-01Annual revision

Lowered numeric thresholds defining high risk of progression from UPCR ≥1.5 g/g or proteinuria ≥1 g/day to UPCR ≥0.8 g/g or proteinuria ≥0.5 g/day and changed initial approval duration to 1 year (applies to initial and continuation therapy).

2024-12-15Selected revision

No criteria changes recorded on this selected revision entry (administrative).